(191 days)
The SCARLET SRF is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The SCARLET SRF includes a system main device, a hand-piece equipped with a tip, and a footswitch. The RF signal is generated from the main device which is then delivered to the handpiece and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the tip. The tip is placed in light contact with the epidermis while the handpiece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SCARLET SRF creates heat within the target skin tissue via needle electrodes from the consumable tip.
The provided document is a 510(k) summary for the SCARLET SRF device, an electrosurgical cutting and coagulation device. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies with specific acceptance criteria as you might see for novel devices.
Therefore, the information you've requested about acceptance criteria and a study proving the device meets those criteria, particularly in the context of diagnostic performance (e.g., sensitivity, specificity, F1 score), MRMC studies, or multi-reader ground truth establishment, is not present in this document. The document describes pre-clinical performance testing related to safety and foundational operational aspects.
However, I can extract the information that is available about the performance data.
Here's the breakdown of the information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of "acceptance criteria" and "reported device performance" in the traditional sense of diagnostic or clinical outcome metrics. Instead, it lists various performance tests and states that the device "met the pre-set criteria" or that "all results were passing."
| Test Category | Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Sterility assurance level of 10-6 (EtO sterilization) | Verified sterility assurance level (10-6) using BI overkill method. |
| Shelf-life Validation | Maintain device integrity and functionality over proposed shelf life | Tests conducted using accelerated aging method. |
| Biocompatibility | Compliance with ISO 10993 standards for patient-contacting components | Tests conducted in accordance with ISO 10993 series and USP 39 . |
| Software Validation | Software (firmware) performance for moderate level of concern | Validation tests performed. |
| EMC & Electrical Safety | Compliance with applicable IEC and EN standards | All results were passing. |
| Max Output Energy | Meet pre-set criteria for maximum output energy per electrode | Test results met pre-set criteria and validated specifications. |
| Preclinical (Animal) Study | Safety and effectiveness as an RF heating device; substantial equivalence to predicates | Demonstrated transient erythema, minimal to mild necrosis, dermal fibrosis, and no other application-related findings. Histology data supported substantial equivalence. |
Important Note: The "acceptance criteria" here are largely inferred from the testing standards and the statement that the tests were successful. They are not quantifiable performance metrics like accuracy, sensitivity, or specificity.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Preclinical Animal Study: Three (3) Yucatan Mini-pigs.
- For other tests (Sterilization, Shelf-life, Biocompatibility, EMC, Electrical Safety, Max Output Energy, Software), the specific sample sizes are not explicitly stated for each test, but standard procedures for these tests would involve appropriate sample sizes of the device/components.
- Data Provenance: The document does not specify the country of origin for the data (e.g., where the animal study was conducted, or where the other tests were performed). It is presumed to be conducted by or for VIOL Co., Ltd., based in South Korea, or their designated testing facilities.
- Retrospective/Prospective: The preclinical animal study was prospective in design (monitoring animals over time after treatment). Other tests are typically prospective (i.e., conducted anew for this device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The preclinical animal study involved histopathology evaluation, which would typically be performed by veterinary pathologists, but the number or qualifications of these experts are not mentioned. For the other technical tests, "ground truth" as you might define it for AI or diagnostic devices does not directly apply; rather, it's about adherence to engineering standards and objective measurements.
4. Adjudication method for the test set
This information is not provided and is generally not applicable to the types of technical and preclinical (animal) tests described in this 510(k) summary. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessment where discrepancies between readers need to be resolved for ground truth establishment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not described. This type of study is relevant for AI-powered diagnostic devices comparing human performance with and without AI assistance, which is not the nature of the SCARLET SRF device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm-only performance study was not done and is not described. The SCARLET SRF is an electrosurgical device, not an AI or diagnostic algorithm, so this type of study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the Preclinical Animal Study: Histopathology evaluation was used to assess the tissue changes.
- For other engineering and safety tests: The "ground truth" is adherence to established international and national standards (e.g., ISO, ASTM, IEC, EN, USP) and the device's own pre-set design specifications. This is based on objective measurements and standard compliance.
8. The sample size for the training set
This information is not applicable and not provided. The SCARLET SRF is an electrosurgical device; it does not involve machine learning algorithms that require a "training set" in the context of AI development.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this device in the context of AI.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.